Doxorubicin(Myocet) 50mg powder, dispersion and solvent for concentrate for dispersion for infusion(八)
re set point by checking the thermometer.
(Please note that whilst the control settings on the water bath and heat block are set to different levels the temperature of the vial contents are in the same range (55°C-60°C)).
Remove the carton of Myocet constituents from the refrigerator.
Step 2. Reconstitute doxorubicin HCl
• Withdraw 20 ml sodium chloride solution for injection (0.9%), (not provided in the package), and inject into each Myocet doxorubicin HCl, intended for preparation.
• Shake well in the inverted position to ensure doxorubicin is fully dissolved.
Step 3. Heat in water bath or dry heat block
• Heat the reconstituted Myocet doxorubicin HCl vial in the Techne DB-3 Dri Block heater with the thermometer in the block reading (75°C-76°C) for 10 minutes (not to exceed 15 minutes). If using the water bath heat the Myocet doxorubicin HCl vial with the thermometer temperature reading 55°C-60°C for 10 minutes (not to exceed 15 minutes).
• While heating proceed to step 4
Step 4. Adjust Ph of liposomes
• Withdraw 1.9 ml of Myocet liposomes. Inject into Myocet buffer vial to adjust the Ph of liposomes. Pressure build-up may require venting.
• Shake well.
Step 5. Add Ph-adjusted liposomes to doxorubicin
• Using syringe, withdraw the entire vial contents of Ph-adjusted liposomes from the Myocet buffer vial.
• Remove the reconstituted Myocet doxorubicin HCl vial from the water bath or dry heat block. SHAKE VIGOROUSLY. Carefully insert a pressure-venting device equipped with a hydrophobic filter. Then IMMEDIATELY (within 2 minutes) inject Ph-adjusted liposomes into vial of heated reconstituted Myocet doxorubicin HCl. Remove venting device.
• SHAKE VIGOROUSLY.
• WAIT for a minimum of 10 MINUTES before using, keeping the medicine at room temperature.
• The Techne DB-3 Dri Block Heater is fully validated for use in the constitution of Myocet. Three inserts, each with two 43.7mm openings per insert must be used. To ensure correct temperature control the use of a 35mm immersion thermometer is recommended.
The resulting reconstituted preparation of Myocet contains 50 mg of doxorubicin HCl/25 ml of liposomal dispersion (2 mg/ml).
After reconstitution the finished product must be further diluted in 0.9% (w/v) sodium chloride for injection, or 5% (w/v) glucose solution for injection to a final volume of 40 ml to 120 ml so that a final concentration of 0.4 mg/ml to 1.2 mg/ml doxorubicin is obtained.
Once constituted, the liposomal dispersion for infusion containing liposome-encapsulated doxorubicin should be a red orange opaque homogeneous dispersion. All parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration. Do not use the preparation if foreign particulate matter is present.
Procedure for proper disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
TEVA B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
8. Marketing authorisation number(s)
EU/1/00/141/001-002
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 13 July 2000
Date of latest renewal: 02 July 2010
10. Date of revision of the text
01/2015
Detailed information on this product is available on the website of the European Medicines Agency http |
